225Ac-J591 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana-Farber Cancer Institute, Boston, MAProstate Cancer225Ac-J591 - Drug
Eligibility
18 - 99
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new prostate cancer treatment that combines two drugs: one that delivers radiation to cancer cells, and one that strengthens the immune system's ability to destroy cancer cells.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Will be collected at the time of visit 1 through 1 year on study

Week 12
Determination of optimal dose of 225Ac-J591 for phase II
Proportion of patients with dose-limiting toxicity (DLT) following treatment with pembrolizumab and 225Ac-J591
Month 100
Change in radiographic progression-free survival
Month 100
Change in overall survival following treatment
Month 100
Change in biochemical progression-free survival
Change in composite response rate of pembrolizumab and ARPI with or without 225Ac-J591
Change in proportion with >30% PSA decline
Change in proportion with >50% PSA decline
Change in proportion with >90% PSA decline
Year 1
Change in proportion with 1-year progression-free survival

Trial Safety

Trial Design

2 Treatment Groups

Pembrolizumab + ARPI
1 of 2
Pembrolizumab + 225Ac-J591 + ARPI
1 of 2

Experimental Treatment

76 Total Participants · 2 Treatment Groups

Primary Treatment: 225Ac-J591 · No Placebo Group · Phase 1 & 2

Pembrolizumab + ARPIExperimental Group · 3 Interventions: Androgen receptor pathway inhibitor, Pembrolizumab, 68Ga-PSMA-11 · Intervention Types: Drug, Drug, DiagnosticTest
Pembrolizumab + 225Ac-J591 + ARPIExperimental Group · 4 Interventions: 225Ac-J591, Androgen receptor pathway inhibitor, Pembrolizumab, 68Ga-PSMA-11 · Intervention Types: Drug, Drug, Drug, DiagnosticTest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
68Ga-PSMA-11
2019
Completed Phase 3
~160

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: will be collected at the time of visit 1 through 1 year on study

Who is running the clinical trial?

United States Department of DefenseFED
792 Previous Clinical Trials
213,251 Total Patients Enrolled
34 Trials studying Prostate Cancer
4,976 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,707 Previous Clinical Trials
4,967,182 Total Patients Enrolled
24 Trials studying Prostate Cancer
16,650 Patients Enrolled for Prostate Cancer
Weill Medical College of Cornell UniversityLead Sponsor
997 Previous Clinical Trials
1,331,789 Total Patients Enrolled
46 Trials studying Prostate Cancer
49,113 Patients Enrolled for Prostate Cancer
Scott Tagawa, MD, MSPrincipal InvestigatorWeill Medical College of Cornell University

Eligibility Criteria

Age 18 - 99 · Male Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Does this experiment have an age restriction?

"This trial is for patients aged 18 to 99. However, if the patient falls outside of that age range, there are 109 studies for those under 18 and 2354 trials for seniors aged 65 and up." - Anonymous Online Contributor

Unverified Answer

How many people are allowed to take part in this experiment?

"That is accurate. The clinicaltrials.gov website has the most recent information regarding this study, which was first posted on 8/12/2021 and last updated 9/27/2022. There are 4 active recruitment sites for the 76 open participant spots." - Anonymous Online Contributor

Unverified Answer

Can new participants join this research project?

"The information available on clinicaltrials.gov indicates that this study is still recruiting patients as of September 27th, 2022. This trial was originally posted on August 12th, 2021 and has been updated several times since then. They are looking for a total of 76 participants that will be spread out between 4 different sites." - Anonymous Online Contributor

Unverified Answer

Could I potentially qualify to participate in this research study?

"Those that wish to take part in this prostate cancer clinical trial must be aged between 18 and 99. There are only 76 spots available in total." - Anonymous Online Contributor

Unverified Answer

What diseases or conditions is 225Ac-J591 commonly used as a therapy for?

"225Ac-J591 is a standard treatment for malignant neoplasms, but can also be used to ameliorate other conditions like microsatellite instability high and disease progression after chemotherapy." - Anonymous Online Contributor

Unverified Answer

Do we have precedent for using 225Ac-J591 in this way?

"City of Hope was the first institution to study 225Ac-J591 back in 2010 and there have been 251 completed trials since then. There are over a thousand studies currently recruiting, with a significant portion being based in Brooklyn, MA." - Anonymous Online Contributor

Unverified Answer

What is the intended outcome of this research?

"The purpose of this study, which will take place over the course of 100 months, is to assess the proportion of patients that experience dose-limiting toxicity following treatment with pembrolizumab and 225Ac-J591. Additionally, researchers will track changes in 1-year progression-free survival rate (defined as imaging or biochemical evidence), changes in biochemical progression-free survival rate (PSA level increase), and changes in overall survival rate." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.